Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Georgetown University

Status and phase: Terminated; Phase 2

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Ofatumumab and Bendamustine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01010568

OB2009-315

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed CLL or SLL requiring therapy
• Age 18 years of age or older
• ECOG performance status 0, 1, or 2
• Normal organ and bone marrow function
• Resolution of toxic effects from prior therapies
• Ability to adhere to the study schedule and give written informed consent

Exclusion criteria

• Any serious medical, psychiatric illness or laboratory abnormality
• Chemotherapy or radiotherapy within 4 weeks of entering the study
• Currently receiving other treatment for CLL/SLL or other malignancies
• Active other malignancies
• History of allergic reactions to bendamustine or ofatumumab
• Ongoing corticosteroid use
• Pregnant or lactating
• HIV positive
• Active hepatitis B
• Allogeneic transplant within 6 months of entering study or graft-versus-host disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ofatumumab and Bendamustine

Experimental group

Description:

Ofatumumab and Bendamustine

Treatment:

Drug: Ofatumumab and Bendamustine